| CTRI Number |
CTRI/2025/04/085793 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
28/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A STUDY TO EVALUATE EFFECTIVENESS OF UNANI COMPOUND DRUG IN KINDEY STONE |
|
Scientific Title of Study
|
A Prospective, Open label, Single-Arm Study to Evaluate the Efficacy of Unani Formulations in the Management of Hasah aL-Kulya (Renal calculus)
|
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR TABISH SHAMSHI |
| Designation |
PG SCHOLAR |
| Affiliation |
DEPARTMENT OF ILMUL JARAHAT STATE TAKMEEL UTTIB COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ILMUL JARAHAT STATE TAKMEEL UTTIB COLLEGE AND HOSPITAL NEAR RAMABAI RALLY STHAL BIJNOR ROAD AURANGABAD TIRAHA lucknow Lucknow UTTAR PRADESH 226002 India |
| Phone |
9457607786 |
| Fax |
|
| Email |
Tabish.raja@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rakhshinda Baig |
| Designation |
Reader Department of Ilmul Jarahat |
| Affiliation |
DEPARTMENT OF ILMUL JARAHAT |
| Address |
DEPARTMENT OF ILMUL JARAHAT STATE TAKMEEL UTTIB COLLEGE AND HOSPITAL DEPARTMENT OF ILMUL JARAHAT STATE TAKMEEL UTTIB COLLEGE AND HOSPITAL NEAR RAMABAI RALLY STHAL BIJNOR ROAD AURANGABAD TIRAHA Lucknow UTTAR PRADESH 226002 India |
| Phone |
9415337189 |
| Fax |
|
| Email |
baigrakhshi12@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Abdul Quavi |
| Designation |
Professor and H.O.D |
| Affiliation |
DEPARTMENT OF ILMUL JARAHAT |
| Address |
DEPARTMENT OF ILMUL JARAHAT STATE TAKMEEL UT TIB COLLEGE AND HOSPITAL
DEPARTMENT OF ILMUL JARAHAT STATE TAKMEEL UTTIB COLLEGE AND HOSPITAL NEAR RAMABAI RALLY STHAL BIJNOR ROAD AURANGABAD TIRAHA Lucknow UTTAR PRADESH 226002 India |
| Phone |
9455077880 |
| Fax |
|
| Email |
quavinium@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Takmeel uttib College and hospital Lucknow Near Ramabai Rally Sthal Bijnaur Road Aurangabad Tiraha 226002 |
|
|
Primary Sponsor
|
| Name |
State Takmeel uttib College and hospital Lucknow |
| Address |
Near Ramabai Rally Sthal Bijnaur Road Aurangabad Tiraha 226002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR TABISH SHAMSHI |
State Takmeel uttib College and hospital Lucknow |
Department of Ilmul Jarahat Near Ramabai Rally Sthal Bijnor Road Aurangabad Tiraha 226002 Lucknow UTTAR PRADESH |
9457607786
Tabish.raja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutinal Ethics commitee State Takmeel Uttib College and Hospital Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Prepared Unani compound Formulation Dawa-e-Gurda include the following ingredients: Hajrul yahood 200gm, sang-e-sar-e-mahi 200gm, jawakhar 200gm, sat-e-barzad 200gm, Alu balu 200gm, Tukhm-e-sarawali 200gm, Habb-e-kaknaj 200gm, Kaf-e-darya 200gm, Habb-ul-qilt 200gm |
Sufoof(Powder) 3gm orally BD For 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed case of Hasah al kulya ( Renal calculus ) upto 10 mm ( Radiological evidence )
Patients who have agreed to sign the informed consent form and follow up the protocol . |
|
| ExclusionCriteria |
| Details |
Patients diagnosed as stone size more than 10 mm or location other than kidney
. urinary bladder outlet obstruction
Known cases of Diabetes mellitus and any serious systemic illness.
Patients having any type of malignancy
Pregnant and lactating women.
Any acute or chronic kidney disease.
Mentally retarted patient.
Patient having severe flank pain, gross haematuria,
severe hydroureteronephrosis and deranged RFT
Patient who fail to give consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain in flank region
Burning micturition
Haematuria
Nausea/ vomiting
Frequency of micturition |
Day 0, 15th 30th
45th |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
USG whole abdomen
Urine R/M
Blood urea and serum creatinine |
0 and 45th day |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Renal stone or calculus is one of the most common disease of urinary tract. it occurs more frequently in men than in women, white than in black and it shows familial predisposition. Urinary stone is a stone like body composed of urinary salts bound together by a colloidal matrix of organic material it consist of a nucleus around which concentric layers of urinary salts are deposited. the primary purpose of protocol is to outline standardized procedure for diagnosing, managing and treating renal stone patient. The protocol aims to provide a clear framework for assessing symptoms, evaluating the severity of the condition , and implementing appropriate interventions to improve patient outcomes and quality of life. this may include life style modification, Diet modification, Medication depending on the severity of the symptoms. Urinary calculi has its roots deeply embedded in urological literature. treatment have changed drastically over the centuries, from lithotripsy to open surgical procedure to removal of stone. Nephrolithiasis or renal calculus affect approximately 15% population worldwide and about 2.3 % population of India. it affects all age groups from less than 1 year of age to more than 70 years of age, with male female ratio 2:1. Urinary stone are among one of the most significant cause of morbidity and end stage renal failure. its rate of recurrence in male is about 70-81% and in female 47-60%. Despite of various technological advent ages in minimal invasive therapy in treatment of renal stone like ESWL, Percutaneous nephrolithotomy the management of renal stone remain challenge due to high cost, adverse effect and complication of minimal invasive technique. The study aims to assess whether these Unani compound formulations can offer significant benefit in alleviating symptoms, improving urinary function and removal of stone. |